- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01128374
The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 Diabetes
The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 DiabetesS
Type 2 diabetes mellitus (T2DM) has become a significant pandemic with more than 7% of the population in the United States affected. Moreover, up to one-third of these individuals may not be aware of the diagnosis and, are not involved in treatment. In the Mexican-American population, prevalence rates may be up to 50%. Contributing factors such as poor education, low household income, language barriers and restricted access to medical services may increase this prevalence. The association between periodontal disease and diabetes has been well documented; however, interventional studies have resulted in conflicting conclusions on improvements in glycemic control following periodontal therapy.
Diabetes and periodontal disease share common pathways in pathogenesis, such as their polygenic nature and immunoregulatory dysfunction. To answer these questions, we, the investigators, propose this randomized controlled trial designed to elucidate how treatment of periodontal disease can be used for preventive and therapeutic purposes in a diabetic population as well as to study the role of IL-1 gene cluster polymorphisms as a risk factor for the presence of periodontitis in a Hispanic T2DM population. Our central hypothesis is that the Mexican-American T2DM population in Texas is at risk for an increased presence and severity of periodontal disease due to the presence of Il-1 gene cluster polymorphisms; furthermore we suggest that providing non-surgical periodontal therapy to this group will decrease the bacterial load associated with disease and as a consequence, will improve glycemic control as measured by HbA1c values. Our long-term goal is to study risk factors associated with the presence of periodontal disease and to understand how the treatment of periodontal disease can be used for preventive and therapeutic purposes in a Hispanic type 2 diabetic population.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center Houston, Dental Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 18 years old
- Diagnosed type 2 diabetes mellitus
- Existence of moderate to severe periodontitis as defined by the American Academy of Periodontology
- In good general health - able to undergo the proposed therapy without compromise to existing health
- Demonstrated ability to read and understand written Spanish or English without the aid of ad-hoc interpretation by a third party
- Demonstrated ability to understand the proposed therapy and possible outcome
- Demonstrated willingness to comply with all protocol requirements as outlined in the informed consent document
- Willingness/ability to sign an informed consent document for their own inclusion in the study
- Hispanic origin as confirmed by patient records
Exclusion Criteria:
- Pregnancy at the time of enrollment (Pregnancy test is required for female study participants of child-bearing potential.)
- Use of antibiotics within last 3 months
- Immunocompromised health status
- Other medical conditions that represent a threat to life
- Osteoporosis
- Biphosphonates, corticosteroids or behavior alteration medications
- Historical abuse of alcohol or drugs
- Use of cigarettes/tobacco products within the past 12 months
- Mental diseases
- Any other oral pathology that compromise the patient's medical status
- Diagnosed type 1 diabetes mellitus (Information will be obtained from the medical records)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention
Therapy
|
Participants will be instructed to brush their teeth using the modified Bass toothbrushing technique; the use of interproximal hygiene aids such as proximal brush or dental floss will be included.
A full mouth scaling and root planning will be performed in 2 appointments (2 hours each) with the use of local anesthesia (typically 2% lidocaine with 1:100,000 epinephrine).
In the control group, this treatment will be performed after all the data and samples have been collected and will encompass the last 2visits.
Periodontal scaling and root planning treatment has been defined by The American Academy of Periodontology (AAP) as the standard of care for patients with periodontal disease.
An ultrasonic instrument, scalers and curettes will be utilized to remove calculus and obtain a smooth root surface.
The experimental subjects will be appointed 1 week later to complete the scaling and root planning procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c percentage
Time Frame: At baseline and 120 days after treatment
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At baseline and 120 days after treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
microbial burden
Time Frame: Baseline and 120 days after therapy
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Baseline and 120 days after therapy
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gene polymorphisms
Time Frame: 120 days after enrolment
|
120 days after enrolment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Isabel C Gay, DDS, MS, University of Texas Health Science Center Dental Branch
- Study Chair: James Katancik, DDS, PhD, University of Texas Health Science Center at Houston Dental Branch
- Study Director: Gena Tribble, PhD, University of Texas Health science Center Houston Dental Branch
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UL1RR024148 (CTSA)
- UL1RR024148 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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